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LEDERLE NOVANTRONE ADVISORY COMMITTEE REVIEW SCHEDULED

Executive Summary

LEDERLE NOVANTRONE ADVISORY COMMITTEE REVIEW SCHEDULED for December, FDA Office of Drug Research & Review Director Robert Temple, MD, told the National Cancer Institute's (NCI) Division of Cancer Treatment Board of Scientific Counselors at its Oct. 2 meeting. "We hope to get [Novantrone] to the advisory committee in December, and anyone who wants to be there can see what the [new] data looks like," Temple said. The upcoming meeting will be the third time FDA's Oncologic Drugs Advisory Committee has reviewed data on Novantrone (mitoxantrone HCl) for the treatment of breast cancer. The committee had asked for more data at the first meeting in March 1985 and recommended approval at the second meeting in March 1986 ("The Pink Sheet" March 17, 1986, p. 3). FDA, however, has not accepted the advisory committee recommendation and requested that Lederle submit additional data that was not available at the time of the second advisory committee review ("The Pink Sheet" Oct. 27, "In Brief"). Temple noted that the agency's rejection of the NDA was based on unfavorable efficacy responses in comparison with Adria's Adriamycin, the comparative agent used in Lederle's trials. Temple indicated that the new data to be reviewed at the December advisory committee meeting may not make Novantrone look any more efficacious for the treatment of breast cancer. In reviewing the NDA after the advisory committee's recommendation for approval, Temple commented, "we were very conscious of the considerably poorer response rate with Novantrone. At the time of the advisory committee meeting, [it was] roughly 28% for Adriamycin v. 19% or 20% for Novantrone." Temple added: "There are now more data, and it doesn't make [Novantrone] look better." Both Temple and FDA Commissioner Young spoke at the board's meeting during a session on FDA policy for approval of anticancer agents. FDA's decision not to approve Novantrone after the advisory committee's approval recommendation served as a focal point for questioning whether FDA's approval criteria for cancer drugs is too stringent. NCI had previously criticized FDA for the Novantrone decision; NCI Director Vincent DeVita, MD, wrote Young in April objecting to the decision and to FDA's cancer drug approval criteria. Explaining FDA's diversion from the advisory committee's recommendation, Temple stated: "There may be an impression that we applied a markedly different standard from our advisory committee when we rejected the application. I think we agreed generally on what the standards should be -- which is reasonable evidence that survival was no worse or perhaps only a little worse than Adriamycin -- but disagreed as to whether this had been demonstrated." While Temple does not appear to be impressed with the new Novantrone breast cancer data, the FDAer indicated that prospects for the leukemia NDA, also pending at the agency, may be favorable. Indirectly referencing the leukemia NDA, Temple commented that "we already know we're going to see very shortly an application for a quite different use [and] I think the data are more impressive." At the board's meeting, NCI Division of Cancer Treatment Director Bruce Chabner, MD, asserted that Novantrone should have been approved for breast cancer, even if survival rates were less than with Adriamycin, based on its low toxicity. Chabner, as well as other board members, urged that FDA revise its drug approval criteria for cancer agents. "For a number of the drugs that we're interested in, such as mitoxantrone, there are advantages in terms of lesser toxicity which can be very important particularly in some patients who are intolerant of the specific toxocity of the standard drug," Chabner said. Young assured the board that the FDA would be looking at its criteria for efficacy and said that he would return to the board's February meeting to report on the agency's progress.
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